Viewing Study NCT00248677



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Study NCT ID: NCT00248677
Status: COMPLETED
Last Update Posted: 2011-12-13
First Post: 2005-11-03

Brief Title: Sensible Treatment of Obesity in Rural Youth
Sponsor: University of Florida
Organization: University of Florida

Study Overview

Official Title: Sensible Treatment of Obesity in Rural Youth
Status: COMPLETED
Status Verified Date: 2011-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Project STORY Sensible Treatment of Obesity in Rural Youth will entail a three-arm randomized controlled trial to test the effectiveness of interventions designed to promote successful weight management in an important population overweight children and their parents in medically underserved rural settings The current feasibility study will provide pilot data to develop and support a full-scale trial that will be implemented across multiple rural counties In this pilot program participants will be randomly assigned to one of two 4-month long intervention programs that will be delivered in rural communities through Cooperative Extension Offices or to a Wait List Control WLC group The Behavioral Family-Based Intervention BFI will involve simultaneous but separate treatment groups for both the child and their parents The Behavioral Parent-Based Intervention BPI will involve groups for only the parents Both programs will take a behavioral lifestyle approach to gradually modify dietary and physical activity patterns The aims of the trial and its principal hypotheses are listed below

AIMS

Evaluate the effects on childs standardized body mass index BMI-z of BPI and BFI delivered via group contacts to overweight children andor their overweight parents in rural counties
Examine changes in childrens dietary intake physical activity self-esteem and body image
Compare the cost-effectiveness of the BPI and BFI
Evaluate the effects of the BPI and BFI on parent BMI
Detailed Description: Project STORY Sensible Treatment of Obesity in Rural Youth will entail a three-arm randomized controlled trial to test the effectiveness of interventions designed to promote successful weight management in an important population overweight children and their parents in medically underserved rural settings The current feasibility study will provide pilot data to develop and support a full-scale trial that will be implemented across multiple rural counties In this pilot program participants will be randomly assigned to one of two 4-month long intervention programs that will be delivered in rural communities through Cooperative Extension Offices or to a Wait List Control WLC group The Behavioral Family-Based Intervention BFI will involve simultaneous but separate treatment groups for both the child and their parents The Behavioral Parent-Based Intervention BPI will involve groups for only the parents Both programs will take a behavioral lifestyle approach to gradually modify dietary and physical activity patterns The aims of the trial and its principal hypotheses are listed below

AIMS

Evaluate the effects on childs standardized body mass index BMI-z of BPI and BFI delivered via group contacts to overweight children andor their overweight parents in rural counties
Examine changes in childrens dietary intake physical activity self-esteem and body image
Compare the cost-effectiveness of the BPI and BFI
Evaluate the effects of the BPI and BFI on parent BMI

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1R34DK071555-01 NIH None httpsreporternihgovquickSearch1R34DK071555-01
R34DK071555 NIH None None